Monthly Archives: July 2017

Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The majorRead more

When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste” from adult trials. Likewise, extrapolation of efficacy and risks from adult studies is not always reliable due to developmental and physiological differences. Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group beingRead more

DURHAM, N.C., JULY 24, 2017 — Premier Research has named Kimberly Glen an Executive Director for Rare Disease, Strategic Development Department. She brings to the company nearly three decades of experience in contract research, drug development, and pharmaceutical consulting. “Rare disease is an extremely demanding field of study, imposing unique challenges in patient recruitment, derivingRead more

DURHAM, N.C., JULY 21, 2017 — Premier Research, seeking to accelerate clinical trial design and patient recruitment to better serve its highly innovative customers, has signed an agreement with TriNetX to allow direct query access to its global health research network, comprised of healthcare organizations representing over 84 million patients globally. The Durham-based contract research organization will use TriNetX’s cloud-based platformRead more

Article 50 was triggered on March 29, 2017, and officially started the two-year negotiation period before the U.K. exits the European Union. The uncertainty of Brexit has left researchers and others in the clinical trials industry nervous about their future. Many of the largest changes for researchers in the U.K. depend on what happens during the nextRead more

For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions. 1. What needs to be defined?Read more

DURHAM, N.C., JULY 18, 2017 — Premier Research has named Susan Romberg Senior Vice President for Clinical Operations. She brings deep industry and therapeutic experience to the role, which oversees global monitoring, clinical management, and document management. Ms. Romberg has worked in the contract research and pharma industries for more than 20 years, most recentlyRead more

The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflectionsRead more

Acne — specifically acne vulgaris — is the most common skin disorder in the United States, affecting up to 50 million Americans each year. While many cases are restricted to mild manifestations during one’s teenage years, acne is a highly visible condition that can have a major impact on a patient’s quality of life. It’s a disorder with the potentialRead more

One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments. Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has anRead more

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